Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 63, 69, 71, 97, 99-100, and 103 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With respect to claim 63, the claim limitation of “the one or more injectable bone inducing agents are predisposed within the porous structure” are unclear. It is noted that the applicant is claiming an implant with an open portion that is “configured to receive one or more injectable bone inducing agents”. Therefore, it is noted that the bone inducing agents are NOT claimed. Therefore, since the applicant is not claiming the bone inducing agents, the limitation of claim 63 as to what is being claimed. It is noted that the limitations are appearing to only functionally claim how the implant can be used, such as it is capable of including bone inducing agents predisposed within the porous structure. It is noted that for examination purposes, the limitation is being interpreted as they can be predisposed before implantation and also in the alternative that they are predisposed, however, the applicant should amend the claim to clarify what is being claimed. Specifically if the applicant wants to require the bone inducing agents, the applicant should make it clear that they are injected before implantation and not necessarily impregnated in the porous structure in order to avoid new matter issues.
The same issue applies to claim 69 and are being interpreted the same as above.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 28, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (2018/0344435) in view of Djemai (WO 2018/100250).
Han teaches with respect to claim 1, a threaded implant 100 comprising an implant body having an external thread 109 on an external surface of the implant body (see figs. 2-3), the implant body comprising an upper portion 102 with an open ceiling 107 configured to receive one or more injectable bone inducing agents (par. 39), a middle portion 13 defining a hollow inner channel 110 (par. 16), and a lower portion 104 with a closed floor 108, wherein the hollow inner channel extends from the open celling to the closed floor (see fig. 3, pars. 17-19), wherein the middle portion defines one or more side openings 106 extending from the hollow inner channel (see fig. 6, par. 47) rotating in a helix-like shape in a same direction as that of a plurality of turns of the external thread (see figs. 1-2, such that they both rotate in a right to left direction), wherein dimensions of the side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth from the hollow inner channel to the surrounding bone (par. 51). Han teaches the invention as substantially claimed and discussed above, however, does not specifically teach wherein a porous structure is disposed within the hollow inner channel, the porous structure defining a plurality of pores, wherein at least one of the plurality of pores is in fluid communication with at least one of the one or more side openings, wherein the porous structure is integrally formed with the implant body.
PNG
media_image1.png
374
685
media_image1.png
Greyscale
Djemai teaches a threaded implant comprising an implant body having an external thread on an external surface of the implant body (see fig. 5), the implant body comprising an upper portion with an open ceiling configured to receive one or more injectable bone inducing agents (see fig. 5, such that the end is open and therefore it is configured to receive one or more injectable bone inducing agent within the opening), a middle portion defining a hollow inner channel, and a lower portion (see fig. 5, annotated figure below), wherein the hollow inner channel extends from the open ceiling to the lower portion (see fig. 5, annotated figure below), wherein the middle portion defines one or more side openings extending from the hollow inner channel, rotating in a helix-like shape, wherein dimensions of the one or more side openings are of sizes designed to enable bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth from the hollow inner channel to the surrounding bone (see pars. 98, 101, specifically par. 101 “the bone has penetrated deeply into the implant”, such that the openings are sized to function as claimed), wherein a porous structure (see fig. 5, annotated figure below) is disposed within the hollow inner channel (see fig. 5, annotated figure below), the porous structure defining a plurality of pores, wherein at least one of the plurality of pores is in fluid communication with at least one of the one or more side openings (see fig. 5, such that the pores are in communication with the openings), wherein the porous structure is integrally formed with the implant body (see par. 85 of translation, such that the fixing element is made integral with the internal body, such that the implant body is the fixing element and the porous structure is the internal body, see pars. 27, 100, 139 of translation). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the implant of Han with the porous structure taught by Djemai in order to ensure bone growth (See par. 4 of translation)
With respect to claim 2 Han/Djemai teaches the invention as substantially claimed and discussed above, including Djemai further teaches the porous structure and the implant body are formed via additive manufacturing to be integrally formed with each other (see pars. 84-85). The claimed phrase “are formed via additive manufacturing” is being treated as a product by process limitation; that is, that the implant body and porous member are made using additive manufacturing techniques. As set forth in MPEP 2113, product by process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
With respect to claim 28, Han/Djemai teaches the invention as substantially claimed and discussed above, Han further teaches the threaded implant further comprising a plug-in screw, a healing cap screw, or an abutment screw removably couplable with the open ceiling, extending into the hollow inner channel (pars. 27, 50, claim 5), wherein the plug-in screw, the healing cap screw, the abutment screw, or any combination thereof define one or more features for engaging a removal instrument (see par; 64 such that the plug in screw can be removed, therefore, it has a feature for engaging with a removal instrument, such that even the surface is a feature to engage with a removal instrument, par. 80 teaching the cover screw/healing being removed).
With respect to claim 30, Han/Djemai teaches the invention as substantially claimed and discussed above, Han further teaches the threaded implant wherein the lower portion comprises one or more self-tapping cuts at a front end of the lower portion (par. 49).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (2018/0344435) in view of in view of Djemai (WO 2018/100250) as applied to claim 1 above, and further in view of Stucki-McCormick (2003/0165795).
In the alternative, Han/Djemai teaches the invention as substantially claimed and discussed above, however, does not specifically teach wherein the plug-in screw, the healing cap screw, the abutment screw, or any combination thereof define one or more features for engaging a removal instrument.
Stucki-McCormick teaches a threaded implant comprising an implant body having an external thread on an external surface of the implant body, the implant body comprising an upper portion with an open ceiling, the implant further comprising an abutment screw 100 removably couplable with the open ceiling and wherein the abutment screw defines a feature 96 for engaging a removal instrument (see figs. 7-8c, par. 89). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the plug-in screw, healing cap screw, or abutment screw of Han/Djemai to include a feature for engaging a removal instrument in order to allow for easy attachment and removal of the elements during the procedure.
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (2018/0344435) in view of in view of Djemai (WO 2018/100250) as applied to claim 1 above, and further in view of Greenhalgh et al. (2019/0167326)
Han/Djemai teaches the invention as substantially claimed and discussed above, however, does not specifically teach the hollow inner channel tapers from a largest diameter closest to the open ceiling to a smallest diameter adjacent the closed floor.
Greenhalgh teaches threaded implant (see fig. 25D) comprising an implant body having an external thread on an external surface of the implant body (see fig. 25D), the implant body comprising an upper portion with an open ceiling configured to receive one or more injectable bone inducing agents (par. 123), a middle portion defining a hollow inner channel (see fig. 25D, such that portion with openings 204 is the hollow channel, such that element 138 is within the channel), and a lower portion with a closed floor(see fig. 25C/D, such that the tip end is the lower portion), wherein the hollow inner channel extends from the open ceiling to the closed floor (see fig. 25C/D) wherein the middle portion defines one or more side openings 204 extending from the hollow inner channel (see fig. 25C/D), wherein a porous structure 138 (par. 287-258) is disposed within the hollow inner channel (see fig. 25D), the porous structure defining a plurality of pores, wherein at least one of the plurality of pores is in fluid communication with at least one of the one or more side openings (see fig. 25D, pars. 257-258 such that they are in communication as fluid is delivered through the porous element to the openings).
Greenhalgh further teaches with respect to claim 34, the hollow inner channel tapers from a largest diameter closest to the open ceiling to a smallest diameter adjacent the floor (see pars. 134, 224 see figs. 17A). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Han/Djemai with the tapered hollow inner chamber in order to assist in the flow of the material, such that the tapered shape helps the fluid flow towards the tip (see par. 133 of Greenhalgh. It is further noted that Greenhalgh teaches a cylindrical inner chamber as taught by Han (see par. 134 of Greenhalgh), therefore, Greenhalgh teaches that the two different shape are known equivalents.
Claim(s) 35, 62-65, 104-105 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim (2015/0230889) in view of Dosta et al. (2009/0208907) in view of Son (KR 20180135557).
Kim teaches with respect to claim 35, threaded implant 100 comprising an implant body having an external thread 109 on an external surface of the implant body, the implant body comprising an upper portion 102 defining an open ceiling 107 configured to receive one or more injectable bone inducing agents (see abstract), a middle portion 103 defining a hollow inner channel 110 (par. 36), and a lower portion 104 with a closed floor 108 (par. 35), wherein the hollow inner channel extends from the open ceiling to the closed floor (abstract, par. 36, fig. 2e, 4) wherein the middle portion defines one or more side openings 106 extending from the hollow inner channel (par 36), rotating in a helix-like shape (par. 6, figs. 2d, 3b, 4), wherein dimensions of the side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth from the hollow inner channel to the surrounding bone (see abstract, par. 15). Kim teaches the invention as substantially claimed and discussed above, however, does not specifically teach a porous structure is separately formed and removably disposed within the hollow inner channel of the implant body, the porous structure defining a plurality of pores, wherein at least one of the plurality of pores is in fluid communication with at least one of the one or more side openings, wherein the porous structure is inserted into the hollow inner channel via the opening ceiling and wherein the porous structure is biodegradable in vivo.
Dosta teaches a threaded implant comprising an implant body 12 having an external thread 13 on an external surface of the implant body, the implant body comprising an upper portion with an open ceiling 17 configured to receive one or more injectable bone inducing agents (see abstract, such that the medicinal preparations are capable of being a bone inducing agent), a middle portion defining a hollow inner channel (see fig. 4, the channel being occupied by the porous insert 15) and a lower portion (the end of the implant), wherein the hollow inner channel extends from the opening ceiling to the lower portion, wherein the middle portion defines one or more side openings 14 extending from the hollow inner channel, wherein dimensions of the one or more side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth form the hollow inner channel to the surround bone (par. 25, 35-36, abstract), wherein a porous structure 15 is separately formed and disposed within the hollow inner channel, the porous structure defining a plurality of pores, wherein at least one of the plurality of pores is in fluid communication with at least one of the one or more side openings (see figs. 3-4, pars. 25, 31, 34, such that par. 25 teaches the two elements being formed separately and par. 33 teaches the porous structure positioned inside the channel). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Kim with the porous structure taught by Dosta in order to provide the implant with a reliable fixation of the implant in the osseous tissue due to a more complete fusion of the osseous tissue with the porous inner implant area (see par. 6 of Dosta). It is noted that Dosta does not specifically teach the porous structure is removably disposed within the hollow inner channel but does teach as discussed above that it is made separately and inserted into the bore. Therefore, it is noted that since it is a separate element and inserted into the bore, it would be removable as claimed. It is noted that the limitation of being removably disposed is functional and therefore, it the apparatus taught by the prior art is capable of functioning as claimed, then the claimed limitations are met. Since, as discussed above in detail, the prior art of Dosta teaches the porous structure being made separately and inserted into the channel, the device is capable of functioning as claimed and therefore, the claimed limitations are met by the prior art. It is further noted that the applicant does not teach an advantage or unexpected result by making the porous structure removable and further teaches both an integral embodiment and the claimed separate parts as an alternative embodiment. Further it is noted that it has been held to be within the general skill of a worker the art to make elements separable (see MPEP 2144.04, V, C). It is further noted that the limitation “the porous structure is inserted into the hollow inner channel via the open ceiling” is a functional limitation, as the applicant is not claiming the method of making or assembling the implant. Such that it is noted that the combination of Kim/Dosta would teach the structure in which the porous structure is inserted into the hollow inner channel via the open ceiling. As it is noted that Kim teaches the only opening into hollow channel being the open ceiling, as the end of the opening is closed by the floor. It is further noted that Kim teaches other agents inserted into the ceiling opening. Dosta further teaches the insertion of the porous structure into an opening. Therefore, it is noted that the combination of Kim/Dosta would teach the claimed implant in which the porous structure would be capable of being inserted into the hollow chamber through the open ceiling. Kim/Dosta teaches the invention as substantially claimed and discussed above, however, does not specifically teach the porous structure is biodegradable in vivo.
Son teaches a dental implant comprising an implant body 10 having an external thread 11a on an external surface of the implant body, a porous structure 20, wherein the porous structure is biodegradable in vivo (see figs. 2-5, pars. 12, 22, 33, 40-41, 47). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the porous structure taught by Kim/Dosta to be biodegradable as taught by Son in order to improve bone adhesion without causing toxicity.
With respect to claim 62, Kim/Dosta/Son teaches the invention as substantially claimed and disclosed above, Kim further teaches the threaded implant further comprising a plug-in screw, a healing cap screw, or an abutment screw removably couplable with the open ceiling, extending into the hollow inner channel (pars. 44, claim 5).
With respect to claim 63, Kim/Dosta/Son teaches the invention as substantially claimed and disclosed above and further wherein the device is capable of allowing injectable bone inducing agents to be predisposed within the porous structure (see 112 rejection above regarding the functionality of this limitation). Such that as user would be able to dispose bone inducing agents within the porous portion before implanting it. In the alternative Son further teaches the bone inducing agents being predisposed within the porous structure (see pars. 34, 37).
With respect to claim 64, Kim/Dosta/Son teaches the invention as substantially claimed and disclosed above Kim further teaches the threaded implant wherein the lower portion comprises one or more self-tapping cuts at a front end of the lower portion (par. 17).
With respect to claim 65, Kim/Dosta/Son teaches the invention as substantially claimed and disclosed above, Kim further teaches wherein the one or more side openings rotate in a helix-like shape in an opposite direction as that of a plurality of turns of the external thread (see fig. 1).
With respect to claim 104, Kim/Dosta/Son teaches the invention as substantially claimed and discussed above, Han further teaches wherein each of the one or more side openings extends along a longitudinal center line, where each of the one or more side openings has a side opening greatest width as measured along the external surface and perpendicular to the longitudinal center line, wherein the side openings greatest width is within the range of 0.1mm to 0.7mm (see par. 15, fig. 3(a), such that the disclosed range includes 0.6-0.7mm which is within the claimed range).
With respect to claim 105, Kim/Dosta/Son teaches the invention as substantially claimed and discussed above, however, does not specifically teach the groove extend 180 degrees about the circumference of the external surface of the implant body. However, it is noted that it would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Kim to have the side openings only extend 180 degree as claimed in order to control the bone growth. It is noted that the applicant does not teach the extension of the groove providing an advantage or an unexpected result. It is noted that the side opening/groove of the prior art is provided for the same purpose as the current invention, providing bone ingrowth, therefore, the extent of the side opening would have been an obvious matter of design choice in order to control the amount of bone ingrowth.
Claim(s) 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim (2015/0230889) in view of Dosta et al. (2009/0208907) in view of Son (KR 20180135557) as applied to claim 35 above, and further in view of Greenhalgh et al. (2019/0167326)
Kim/Dosta/Son teaches the invention as substantially claimed and discussed above, however, does not specifically teach the hollow inner channel tapers from a largest diameter closest to the open ceiling to a smallest diameter adjacent the closed floor.
Greenhalgh teaches threaded implant (see fig. 25D) comprising an implant body having an external thread on an external surface of the implant body (see fig. 25D), the implant body comprising an upper portion with an open ceiling configured to receive one or more injectable bone inducing agents (par. 123), a middle portion defining a hollow inner channel (see fig. 25D, such that portion with openings 204 is the hollow channel, such that element 138 is within the channel), and a lower portion with a closed floor(see fig. 25C/D, such that the tip end is the lower portion), wherein the hollow inner channel extends from the open ceiling to the closed floor (see fig. 25C/D) wherein the middle portion defines one or more side openings 204 extending from the hollow inner channel (see fig. 25C/D), wherein a porous structure 138 (par. 287-258) is disposed within the hollow inner channel (see fig. 25D), the porous structure defining a plurality of pores, wherein at least one of the plurality of pores is in fluid communication with at least one of the one or more side openings (see fig. 25D, pars. 257-258 such that they are in communication as fluid is delivered through the porous element to the openings).
Greenhalgh further teaches with respect to claim 68, the hollow inner channel tapers from a largest diameter closest to the open ceiling to a smallest diameter adjacent the floor (see pars. 134, 224 see figs. 17A). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Kim/Dosta/Som with the tapered hollow inner chamber in order to assist in the flow of the material, such that the tapered shape helps the fluid flow towards the tip (see par. 133 of Greenhalgh. It is further noted that Greenhalgh teaches a cylindrical inner chamber as taught by Kim (see par. 134 of Greenhalgh), therefore, Greenhalgh teaches that the two different shape are known equivalents.
Claim(s) 35-36, 62-64 and 104-105 is/are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (2018/0344435) in view of in view of Dosta et al. (2009/0208907) in view of Son (KR 20180135557).
Han teaches with respect to claim 35, a threaded implant 100 comprising an implant body having an external thread 109 on an external surface of the implant body (see figs. 2-3), the implant body comprising an upper portion 102 with an open ceiling 107 configured to receive one or more injectable bone inducing agents (par. 39), a middle portion 13 defining a hollow inner channel 110 (par. 16), and a lower portion 104 with a closed floor 108, wherein the hollow inner channel extends from the open celling to the closed floor (see fig. 3, pars. 17-19), wherein the middle portion defines one or more side openings 106 extending from the hollow inner channel (see fig. 3, par. 47) rotating in a helix-like shape (see figs. 1-2, such that they both rotate in a right to left direction), wherein dimensions of the side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth from the hollow inner channel to the surrounding bone (par. 20). Han teaches the invention as substantially claimed and discussed above, however, does not specifically teach a porous structure is disposed within the hollow inner channel, the porous structure defining a plurality of pores, wherein at least one of the plurality of pores is in fluid communication with the at least one of the one or more side openings.
Dosta teaches a threaded implant comprising an implant body 12 having an external thread 13 on an external surface of the implant body, the implant body comprising an upper portion with an open ceiling 17 configured to receive one or more injectable bone inducing agents (see abstract, such that the medicinal preparations are capable of being a bone inducing agent), a middle portion defining a hollow inner channel (see fig. 4, the channel being occupied by the porous insert 15) and a lower portion (the end of the implant), wherein the hollow inner channel extends from the opening ceiling to the lower portion, wherein the middle portion defines one or more side openings 14 extending from the hollow inner channel, wherein dimensions of the one or more side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth form the hollow inner channel to the surround bone (par. 25, 35-36, abstract), wherein a porous structure 15 is separately formed and disposed within the hollow inner channel, the porous structure defining a plurality of pores, wherein at least one of the plurality of pores is in fluid communication with at least one of the one or more side openings (see figs. 3-4, pars. 25, 31, 34, such that par. 25 teaches the two elements being formed separately and par. 33 teaches the porous structure positioned inside the channel). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Kim with the porous structure taught by Dosta in order to provide the implant with a reliable fixation of the implant in the osseous tissue due to a more complete fusion of the osseous tissue with the porous inner implant area (see par. 6 of Dosta). It is noted that Dosta does not specifically teach the porous structure is removably disposed within the hollow inner channel but does teach as discussed above that it is made separately and inserted into the bore. Therefore, it is noted that since it is a separate element and inserted into the bore, it would be removable as claimed. It is noted that the limitation of being removably disposed is functional and therefore, it the apparatus taught by the prior art is capable of functioning as claimed, then the claimed limitations are met. Since, as discussed above in detail, the prior art of Dosta teaches the porous structure being made separately and inserted into the channel, the device is capable of functioning as claimed and therefore, the claimed limitations are met by the prior art. It is further noted that the applicant does not teach an advantage or unexpected result by making the porous structure removable and further teaches both an integral embodiment and the claimed separate parts as an alternative embodiment. Further it is noted that it has been held to be within the general skill of a worker the art to make elements separable (see MPEP 2144.04, V, C). It is further noted that the limitation “the porous structure is inserted into the hollow inner channel via the open ceiling” is a functional limitation, as the applicant is not claiming the method of making or assembling the implant. Such that it is noted that the combination of Han/Dosta would teach the structure in which the porous structure is inserted into the hollow inner channel via the open ceiling. As it is noted that Han teaches the only opening into hollow channel being the open ceiling, as the end of the opening is closed by the floor. It is further noted that Kim teaches other agents inserted into the ceiling opening. Dosta further teaches the insertion of the porous structure into an opening. Therefore, it is noted that the combination of Han/Dosta would teach the claimed implant in which the porous structure would be capable of being inserted into the hollow chamber through the open ceiling. Han/Dosta teaches the invention as substantially claimed and discussed above, however, does not specifically teach the porous structure is biodegradable in vivo.
Son teaches a dental implant comprising an implant body 10 having an external thread 11a on an external surface of the implant body, a porous structure 20, wherein the porous structure is biodegradable in vivo (see figs. 2-5, pars. 12, 22, 33, 40-41, 47). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the porous structure taught by Han/Dosta to be biodegradable as taught by Son in order to improve bone adhesion without causing toxicity.
With respect to claim 36, Han/Dosta/Son teaches the invention as substantially claimed and discussed above, Han further teaches wherein the one or more side openings rotate in the helix like shape in a same direction as that of a plurality of turns of the external thread (see figs. 1-3).
With respect to claim 62, Han/Dosta/Son teaches the invention as substantially claimed and discussed above, Han further teaches the threaded implant further comprising a plug-in screw, a healing cap screw, or an abutment screw removably couplable with the open ceiling, extending into the hollow inner channel (pars. 27, 50, claim 5).
With respect to claim 63, Han/Dosta/Son teaches the invention as substantially claimed and disclosed above and further wherein the device is capable of allowing injectable bone inducing agents to be predisposed within the porous structure (see 112 rejection above regarding the functionality of this limitation). Such that as user would be able to dispose bone inducing agents within the porous portion before implanting it. In the alternative Son further teaches the bone inducing agents being predisposed within the porous structure (see pars. 34, 37).
With respect to claim 64, Han/Dosta/Son teaches the invention as substantially claimed and discussed above, Han further teaches the threaded implant wherein the lower portion comprises one or more self-tapping cuts at a front end of the lower portion (par. 49).
With respect to claim 104, Han/Dosta/Son teaches the invention as substantially claimed and discussed above, Han further teaches wherein each of the one or more side openings extends along a longitudinal center line, where each of the one or more side openings has a side opening greatest width as measured along the external surface and perpendicular to the longitudinal center line, wherein the side openings greatest width is within the range of 0.1mm to 0.7mm (see par. 47, fig. 2, such that the disclosed range includes 0.6-0.7mm which is within the claimed range).
With respect to claim 105, Hab/Dosta/Son teaches the invention as substantially claimed and discussed above, however, does not specifically teach the groove extend 180 degrees about the circumference of the external surface of the implant body. However, it is noted that it would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Kim to have the side openings only extend 180 degree as claimed in order to control the bone growth. It is noted that the applicant does not teach the extension of the groove providing an advantage or an unexpected result. It is noted that the side opening/groove of the prior art is provided for the same purpose as the current invention, providing bone ingrowth, therefore, the extent of the side opening would have been an obvious matter of design choice in order to control the amount of bone ingrowth.
Claim(s) 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (2018/0344435) in view of Dosta et al. (2009/0208907) in view of Son (KR 20180135557) as applied to claim 35 above, and further in view of Greenhalgh et al. (2019/0167326).
Han/Dosta/Son teaches the invention as substantially claimed and discussed above, however, does not specifically teach the hollow inner channel tapers from a largest diameter closest to the open ceiling to a smallest diameter adjacent the closed floor.
Greenhalgh teaches threaded implant (see fig. 25D) comprising an implant body having an external thread on an external surface of the implant body (see fig. 25D), the implant body comprising an upper portion with an open ceiling configured to receive one or more injectable bone inducing agents (par. 123), a middle portion defining a hollow inner channel (see fig. 25D, such that portion with openings 204 is the hollow channel, such that element 138 is within the channel), and a lower portion with a closed floor(see fig. 25C/D, such that the tip end is the lower portion), wherein the hollow inner channel extends from the open ceiling to the closed floor (see fig. 25C/D) wherein the middle portion defines one or more side openings 204 extending from the hollow inner channel (see fig. 25C/D), wherein a porous structure 138 (par. 287-258) is disposed within the hollow inner channel (see fig. 25D), the porous structure defining a plurality of pores, wherein at least one of the plurality of pores is in fluid communication with at least one of the one or more side openings (see fig. 25D, pars. 257-258 such that they are in communication as fluid is delivered through the porous element to the openings).
Greenhalgh further teaches with respect to claim 68, the hollow inner channel tapers from a largest diameter closest to the open ceiling to a smallest diameter adjacent the floor (see pars. 134, 224 see figs. 17A). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Han/Dosta/Som with the tapered hollow inner chamber in order to assist in the flow of the material, such that the tapered shape helps the fluid flow towards the tip (see par. 133 of Greenhalgh. It is further noted that Greenhalgh teaches a cylindrical inner chamber as taught by Han (see par. 134 of Greenhalgh), therefore, Greenhalgh teaches that the two different shape are known equivalents.
Claim(s) 69, 71, 97, and 99-100 is/are rejected under 35 U.S.C. 103 as being unpatentable over Caterini (WO 01/05325) in view of Han et al. (2018/034435) in view of Son (KR 20180135557).
Caterini teaches with respect to claim 69 a threaded implant comprising an implant body having an external thread on an external surface of the implant body (see fig. 3), the implant body comprising an upper portion defining an open ceiling and terminating at a divider (see fig. 3, such that the opening ceiling is 9 and the divider is between 9 and 16), a middle portion defining a hollow inner channel 16, and a lower portion with an open ending tip configured to receive one or more injectable one inducing agents (see fig. 3, such that the end near 7 is open and capable of functioning as claimed), wherein the hollow inner channel extends form the divider to the open ending tip (see fig. 3), wherein the middle portion defines one or more side openings 6 extending from the hollow inner channel (pg. 5, par. 6 starting “The dental implant 2 will”, see fig. 6a), wherein dimensions of the one or more side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth from the hollow inner channel to the surrounding bone (pg. 5, par. 6 starting “The dental implant 2 will”, see fig. 6a), wherein a porous structure 17 defining a plurality of pores is separably formed and disposed within the hollow inner channel (pg. 5, 3rd paragraph “a porous core of substantially cylindrical shape 17 is inserted”, 4th paragraph “After being fitted into the lower hole16”, which teaches the inserted is formed separately since it is inserted), wherein at least one of the plurality of pores is in fluid communication with at least one of the one or more side openings (see fig. 6a), wherein the open ending tip of the lower portion of the implant body is configured to receive the porous structure (see fig. 3, 6a, such that 6a is an enlarged view of 3 showing the openings). Caterini teaches the invention as substantially claimed and discussed above, however, does not specifically teach the one or more side openings are helix-like shape and the bone inducing agent is predisposed within the porous structure prior to the threaded implant being implanted, wherein the porous structure is biodegradable in vivo.
Han teaches a threaded implant 100 comprising an implant body having an external thread 109 on an external surface of the implant body (see figs. 2-3), the implant body comprising an upper portion 102 with an open ceiling 107, a middle portion 103 defining a hollow inner channel 110 (par. 16), and a lower portion, wherein the middle portion defines one or more side openings 106 extending from the hollow inner channel (see fig. 3, par. 47) rotating in a helix-like shape (see figs. 1-2, such that they both rotate in a right to left direction), wherein dimensions of the side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth from the hollow inner channel to the surrounding bone (par. 51). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the shape of the openings taught by Caterini with the helix like shape of Han in order to allow for the desired bone ingrowth. It is noted that Caterini teaches the openings can be a variety of shapes including radial (see pg. 6, last full paragraph). Therefore the shape of the openings is taught as a design choice. Caterini/Han teaches the invention as substantially claimed and discussed above, however, does not specifically the bone inducing agent is configured to be injected into and predisposed within the porous structure prior to the threaded implant being implanted, wherein the porous structure is biodegradable in vivo.
Son teaches a dental implant comprising an implant body 10 having an external thread 11a on an external surface of the implant body, a porous structure 20, and wherein one ore more injectable bone inducing agents are configured to be injected into and predisposed within the porous structure prior to the threaded implant being implanted ( see figs. 2-5, pars. 12, 22, 33, 40-41, 44-47, 55, such that the drug delivering material, i.e. the bone inducing agents, are mixed with the binder material which is the porous material, it is capable of being introduced by injection), wherein the porous structure is biodegradable in vivo (see figs. 2-5, pars. 12, 22, 33, 40-41, 47). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the porous structure taught by Caterini/Han to be biodegradable as taught by Son in order to improve bone adhesion without causing toxicity.
With respect to claim 71, Caterini/Han/Son teaches the invention as substantially claimed and discussed above, Han further teaches wherein the one or more side openings rotate in a helix-like shape in a same direction as that of a plurality of turns of the external thread (see figs. 1-3). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the shape of the openings taught by Caterini with the helix like shape of Han in order to allow for the desired bone ingrowth. It is noted that Caterini teaches the openings can be a variety of shapes including radial (see pg. 6, last full paragraph). Therefore the shape of the openings is taught as a design choice.
With respect to claim 97 Caterini/Han/Son teaches the invention as substantially claimed and discussed above, Caterini further teaches an abutment 3, however, does not specifically teach the abutment is a screw. Han further teaches wherein the threaded implant further comprising a plug-in screw, a healing cap screw, or an abutment screw removably couplable with the open ceiling, extending into the hollow inner channel (par. 64, claim 5). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the abutment of Caterini with the threaded abutment as taught by Han in order to easily attach and remove the abutment as needed.
With respect to claim 99, Caterini/Han/Son teaches the invention as substantially claimed and discussed above, Han further teaches the threaded implant wherein the lower portion comprises one or more self-tapping cuts at a front end of the lower portion (pars. 49, 65). It would have been obvious to one having ordinary skill in the art to modify the implant of Caterini to include self-tapping threads as taught by Han in order to easily install the implant such that the threads do not need to be tapped in an additional step.
With respect to claim 100, Caterini/Han/Lee teaches the invention as substantially claimed and discussed above, Son further teaches wherein the one or more injectable bone inducing agents include bone morphogenetic proteins (see pars. 18, 37). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Caterini/Han to include bone inducing agents within the porous structure as taught by Son in order to promote bone formation.
Claim(s) 69, 97, 99-100 and 103 is/are rejected under 35 U.S.C. 103 as being unpatentable over Caterini (WO 01/05325) in view of Kim (2015/0230889) in view of Son (KR 20180135557).
Caterini teaches with respect to claim 69 a threaded implant comprising an implant body having an external thread on an external surface of the implant body (see fig. 3), the implant body comprising an upper portion defining an open ceiling and terminating at a divider (see fig. 3, such that the opening ceiling is 9 and the divider is between 9 and 16), a middle portion defining a hollow inner channel 16, and a lower portion with an open ending tip configured to receive one or more injectable one inducing agents (see fig. 3, such that the end near 7 is open and capable of functioning as claimed), wherein the hollow inner channel extends form the divider to the open ending tip (see fig. 3), wherein the middle portion defines one or more side openings 6 extending from the hollow inner channel (pg. 5, par. 6 starting “The dental implant 2 will”, see fig. 6a), wherein dimensions of the one or more side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth from the hollow inner channel to the surrounding bone (pg. 5, par. 6 starting “The dental implant 2 will”, see fig. 6a), wherein a porous structure 17 defining a plurality of pores is separably formed and disposed within the hollow inner channel (pg. 5, 3rd paragraph “a porous core of substantially cylindrical shape 17 is inserted”, 4th paragraph “After being fitted into the lower hole16”, which teaches the inserted is formed separately since it is inserted), wherein at least one of the plurality of pores is in fluid communication with at least one of the one or more side openings (see fig. 6a), wherein the open ending tip of the lower portion of the implant body is configured to receive the porous structure (see fig. 3, 6a, such that 6a is an enlarged view of 3 showing the openings). Caterini teaches the invention as substantially claimed and discussed above, however, does not specifically teach the one or more side openings are helix-like shape and the bone inducing agent is configured to be injected into and predisposed within the porous structure prior to the threaded implant being implanted, wherein the porous structure is biodegradable in vivo.
Kim teaches threaded implant 100 comprising an implant body having an external thread 109 on an external surface of the implant body, the implant body comprising an upper portion 102 defining an open ceiling, a middle portion 103 defining a hollow inner channel 110 (par. 14), and a lower portion 104, wherein the middle portion defines one or more side openings 106 extending from the hollow inner channel (par 36), rotating in a helix-like shape (par. 15, figs. 2d, 3b, 4), wherein dimensions of the side openings are of sizes designed to enable bone and bone tissue ingrowth into the hollow inner channel and bone and bone tissue outgrowth from the hollow inner channel to the surrounding bone (see abstract, par. 15). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the shape of the openings taught by Caterini with the helix like shape of Kim in order to allow for the desired bone ingrowth. It is noted that Caterini teaches the openings can be a variety of shapes including radial (see pg. 6, last full paragraph). Therefore the shape of the openings is taught as a design choice. Caterini/Kim teaches the invention as substantially claimed and discussed above, however, does not specifically the bone inducing agent is configured to be injected into and predisposed within the porous structure prior to the threaded implant being implanted, wherein the porous structure is biodegradable in vivo.
Son teaches a dental implant comprising an implant body 10 having an external thread 11a on an external surface of the implant body, a porous structure 20, and wherein one or more injectable bone inducing agents are configured to be injected into and predisposed within the porous structure prior to the threaded implant being implanted ( see figs. 2-5, pars. 12, 22, 33, 40-41, 44-47, 55, such that the drug delivering material, i.e. the bone inducing agents, are mixed with the binder material which is the porous material, it is capable of being introduced by injection), wherein the porous structure is biodegradable in vivo (see figs. 2-5, pars. 12, 22, 33, 40-41, 47). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the porous structure taught by Caterini/Kim to be biodegradable as taught by Son in order to improve bone adhesion without causing toxicity.
With respect to claim 97 Caterini/Kim/Son teaches the invention as substantially claimed and discussed above, Caterini further teaches an abutment 3, however, does not specifically teach the abutment is a screw. Kim further teaches wherein the threaded implant further comprising a plug-in screw, a healing cap screw, or an abutment screw removably couplable with the open ceiling, extending into the hollow inner channel (pars. 18, 44, claim 5). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the abutment of Caterini with the threaded abutment as taught by Kim in order to easily attach and remove the abutment as needed.
With respect to claim 99, Caterini/Kim/Son teaches the invention as substantially claimed and discussed above, Kim further teaches the threaded implant wherein the lower portion comprises one or more self-tapping cuts at a front end of the lower portion (par. 17). It would have been obvious to one having ordinary skill in the art to modify the implant of Caterini to include self-tapping threads as taught by Kim in order to easily install the implant such that the threads do not need to be tapped in an additional step.
With respect to claim 100, Caterini/Kim/Son teaches the invention as substantially claimed and discussed above, Son further teaches wherein the one or more injectable bone inducing agents include bone morphogenetic proteins (see pars. 18, 37). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Caterini/Kim to include bone inducing agents within the porous structure as taught by Son in order to promote bone formation.
With respect to claim 103, Caterini/Kim/Son teaches the invention as substantially claimed and disclosed above, Kim further teaches wherein the one or more side openings rotate in a helix-like shape in an opposite direction as that of a plurality of turns of the external thread (see fig. 1). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the shape of the openings taught by Caterini with the helix like shape of Kim in order to allow for the desired bone ingrowth.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
With respect to claim 35, the applicant argues that the prior art of Kim in view of Dosta and Han in view of Dosta does not teach the limitation of the porous structure being inserted into the hollow inner channel via the open ceiling. It is noted that that applicant is not claiming the method of use or assembly and therefore, the limitation is being interpreted as functional. Such that it is noted that the combination of Kim/Dosta and Han/Dosta would teach the structure in which the porous structure is inserted into the hollow inner channel via the open ceiling. As it is noted that Kim and Han teaches the only opening into hollow channel being the open ceiling, as the end of the opening is closed by the floor. It is further noted that Kim and Han teaches other agents inserted into the ceiling opening. Dosta further teaches the insertion of the porous structure into an opening. Therefore, it is noted that the combination of Kim/Dosta and Han/Dosta would teach the claimed implant in which the porous structure would be capable of being inserted into the hollow chamber through the open ceiling. It is noted that Dosta is NOT being modified and that the prior art of Kim and Han is being modified to teach inserting a porous structure into the opening, such that the opening is open at the ceiling as claimed.
The applicant further argues that one having ordinary skill in the art would not modify Caterini with Han or Kim as Caterini does not have an opening at the top communicating with inner channel as taught by Han and Kim. However, it is noted that Han and Kim is NOT being modified with Caterini which would result in the closed off channel. Rather Caterini with the closed channel and elongated openings is being modified with Han and Kim to teach spiral side openings. It is noted that the modification of Caterini with Han and Kim would not change the principal operation of Caterini and therefore, the applicant’s arguments are moot.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The prior art of Livne was cited to teach a hydrogel with bone promoting agent in a dental implant.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEIDI MARIE EIDE whose telephone number is (571)270-3081. The examiner can normally be reached Mon-Fri 9:00-4:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edelmira Bosques can be reached at 571-270-5614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HEIDI M EIDE/Primary Examiner, Art Unit 3772 8/19/2026
Prosecution Insights